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Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.

Recruitingn/aAges 18 Years - anyAllCartilage Repair Systems BV
NCT06809231 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

CartiONE is a technique used in autologous articular-chondrocyte-based treatments for symptomatic focal articular-cartilage lesions of the knee. The CartiONE technique was evaluated in combination with an osteochondrally placed, biodegradable, biocompatible, load-bearing copolymer (PolyActive) scaffold in the INSTRUCT trial (NCT01041885). To evaluate the clinical effectiveness of the CartiONE technique and confirm its safety, in this study retrospective baseline data and follow-up data, documented as per the standard of care at the participating hospitals, will be collected for patients who were treated with CartiONE. The potential number of patients in this study is 122 and involves patients treated with CartiONE from 2010 to 2023 with a minimum follow-up period of six months, spread across five countries: Belgium, England, Greece, Poland, and Austria.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients treated with CartiONE for knee cartilage lesion more than 6months prior to inclusion in this study. * The study site holds a patient record of all relevant medical history data, including operation reports of any prior knee surgeries, the index-knee surgery report, and posttreatment observations and re-intervention reports, if applicable. Exclusion Criteria: * Patients cannot be included if any condition exists that is judged by the treating surgeon as making the patient not suited for participation.
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What it tests

  • Not listed
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Where

5 sites
UZ Ghent
Ghent, Belgium
AZ Monica
Antwerp, Belgium
MIRAI
Warsaw, Poland
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom
Robert Jones & Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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